For many years, surgical implantation of a penile prosthesis was a common treatment for impotence. More recently, however, non-invasive devices have been designed and prescribed for the external management of erectile dysfunction. Because of the cost and possible risks involved with surgically implanted prostheses, their use is now typically reserved for men for whom more conservative treatments have failed or proven unsuitable. External constriction devices have been provided which contract around the base of the flaccid penis and prevent the outflow of blood once the penis has risen into an erect state. Conventional constriction devices include several different styles which are best explained by three categories.
The first category encompasses external prosthetic devices which comprise large aprons or shields with elongated cylindrical sleeves. Designed to aid in the maintenance of an erection, these devices are placed over the penis and fastened to the body with ties or adhesives. Although these devices enable the user to maintain an erection, they contribute little to the user's ability to achieve a satisfactory erection. A large portion of the user's genitalia, groin and adjacent region must be covered in order for these devices to be securely fastened and function properly, resulting in the user's decreased sensitivity to intimate touching and sexual stimulation. Examples of the apron and shield devices include those disclosed in U.S. Pat. No. 1,608,806, issued Nov. 30, 1926 to Peter W. Nelson, and U.S. Pat. No. 4,872,462, issued Oct. 10, 1989 to Gilbert Salz. Such devices have not been successfully adapted for use with external erection devices.
The second category includes smaller, less cumbersome devices, known as constricting bands or rings which can be used alone or in combination with an external erection device. Once an erection is achieved, the constricting device impedes the flow of blood from the penis, keeping it in an erect state. These devices are typically made of an elastomeric material such as rubber. Constriction bands resemble conventional rubber bands and may range up to about 3/8 of an inch in width. The bands generally include an attached safety release loop made of string, thread, monofilament line, or the like, for use in placement and removal of the bands from the base of the penis.
In contrast, constriction rings generally consist of "O" rings with "C" shaped handles for ease in application and removal. By grasping the handles, the central "O" ring is stretched and placed over the base of the penis where it constricts the retraction vessels to prevent the outflow of blood. Such devices include U.S. Pat. No. 3,759,253, issued on Sep. 18, 1973 to Charles A. Cray and U.S. Pat. No. 4,539,980 issued on Sep. 10, 1985 to John L. Chaney.
When used alone, the constriction rings or bands are placed around the base of the flaccid or semi-flaccid penis, constricting the blood vessels of the penis before it is brought to an erect state. The penis is then massaged or otherwise manipulated to encourage blood flow into the penis wherein the constriction bands or rings prevent the outflow of blood and enable the user to achieve and maintain an erection.
A third category includes constriction devices specifically designed for use with suction or vacuum erection devices. Such constriction devices include a compression ring as disclosed in U.S. Pat. No. 1,225,341 issued on May 8, 1917 to Otto Lederer, a device with a short elastic sleeve as disclosed in Swiss Patent No. 347,300, granted on Jun. 30, 1960 to Guiseppi Meldi, or an elastic sleeve with an expansible diaphragm disclosed in U.S. Pat. No. 4,641,638, issued on Feb. 10, 1987 to Robert D. Perry.
The devices of the second and third categories have been used in combination with conventional, commercially available vacuum erection devices. Vacuum erection devices typically comprise an elongated evacuation cylinder, sometimes with tapered sidewalls, and are generally made of a hard, clear polymeric resin closed at one end and open at the other. The cylinder has a length and diameter sufficiently large to accommodate either a flaccid or an erect penis. Near the closed end of the cylinder, a radially extending port is provided with a fitting that is adapted to be connected by flexible tubing to a manually operable vacuum pump.
Constriction bands, rings and sleeves are provided with the vacuum erection device to be applied to the penis for the purpose of maintaining the erection achieved through use of the vacuum pump. Use of bands or rings with a vacuum erection device requires that either one ring or several bands, doubled or redoubled, be slipped over the open end of the plastic cylinder. Lubricant such as a water-soluble lubricating jelly is desirably applied to the end of the cylinder to facilitate application and removal of the bands or ring.
Once the band or ring is in place around the end of the cylinder, the cylinder is slipped over the flaccid penis and pressed against the groin. In some devices, the closed end of the cylinder is flat or textured to permit it to be braced against a stationary structure such as a table edge. This is done to assist the user in holding the cylinder firmly against the pubic bone, thereby promoting a better seal around the open end of the cylinder and simultaneously freeing the hands of the user to connect and operate the vacuum pump.
While pressing the cylinder firmly against the body around the base of the penis, the vacuum pump is operated to evacuate the cylinder. This reduction of the atmospheric pressure around the penis causes blood to engorge the penis, bringing it to an erect state.
Once erection is achieved, the constriction ring or band is slipped off the open end of the cylinder, whereupon it contracts around the base of the erect penis. Placement of the ring or band around the erect penis significantly restricts the flow of blood back out of the penis, thereby maintaining the penis in an erect state until such time as the ring or bands are removed following intimate sexual activity such as intercourse.
Removal of the bands requires the user to locate and pull the safety loops attached to the bands until the constriction device is expanded sufficiently to permit the user to grasp the bands themselves for removal from the penis. Similarly, ring removal requires the user to locate and grasp the two handles and sufficiently expand the "O" ring to permit removal from the penis.
Several disadvantages have been encountered through use of conventional constriction bands and rings either alone or with commercially available vacuum erection devices. Conventional bands become twisted when doubling them prior to placement upon the penis or when sliding them over the open end of the plastic cylinder, and are further twisted when sliding them off of the cylinder and onto the base of the erect penis, causing undesirable discomfort to the user. Often, pubic hair becomes intertwined with the ring or bands as they are slipped off the cylinder and contracted around the base of the penis which can be very painful to the user during intimate activity and removal. The safety loops attached to the bands can also become wrapped in the bands and pubic hair, making them difficult for the user to grasp during the removal process. When a user has difficulty removing a ring or bands, the user must pull the constricting device away from the penis and cut it with scissors or a knife, taking precautions to avoid injury.
Moreover, because conventional bands, rings and sleeves are not flush against the open end of the evacuation cylinder and do not conform to the surface area of the user's groin, they do not assist in establishing or maintaining an airtight seal around the open end of the vacuum cylinder during evacuation. Since the surfaces of existing constriction devices such as those disclosed in Cray, Chaney, Lederer, Meldi, and Perry fail to provide an air-tight seal between the open end of the cylinder and the constricting device during pumping and evacuation, the effectiveness of the vacuum cylinder for creating a satisfactory penile erection is significantly reduced.
Prior art, such as the Cray and Chaney constriction rings, Lederer compression rings or the Meldi and Perry sleeves do not contain any disclosure or teaching of their use or adaptability as a combination seal and constricting device. The constriction rings of the Cray and Chaney devices, with either a trefoil or circular opening, and the Lederer compression ring, composed of a plurality of disconnectable thin disks, do not have a seating surface adaptable to conform to the user's groin and the open end of the vacuum cylinder to provide an airtight seal.
Although the constriction device disclosed in Meldi is specifically designed for use with a vacuum erection device, it too lacks the means for effectively creating an air-tight seal. A circular device with a short sleeve, it is held in place inside the open end of the cylinder with two small tabs that fold over the outer edge of the cylinder. With no means to create an air-tight seal around the circumference of the open end of the cylinder, such as skirt radially extended beyond the circumference of the open end of the vacuum cylinder, the tabs merely serve to prevent the constricting device from slipping out of position during operation of the vacuum erection device.
The inherent nature of the expansible diaphragm sleeve disclosed in Perry provides a changing wall thickness and sloped, tapered skirt which does not conform to the user's groin area or the circumference of the evacuation cylinder. In this case, the inherent gaps caused by the sloped and tapered skirt prevent the user from establishing an airtight seal around the open end of the evacuation cylinder.
A new means is therefore needed that will safely and comfortably serve as a combination seal and constricting device. Such a means is provided herein.